Predicate Analysis
Map the FDA predicate landscape and recent clearances in your category, substantial equivalence opportunities and competitive intelligence in one structured pass.
Overview
Predicate selection is one of the most consequential pre-submission decisions and one of the most frequently rushed. The wrong predicate adds months to your submission. The right predicate accelerates clearance and provides competitive intelligence you cannot get any other way.
We run the analysis systematically: every relevant prior clearance in your category, mapped against your device, ranked for substantial equivalence strength.
Our Process
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1
Category scan
All 510(k) and De Novo clearances in your product category over the past 5-7 years.
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2
Substantial equivalence mapping
Per candidate: intended use, technological characteristics, performance data.
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3
Predicate strength ranking
Best candidates surfaced with rationale.
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4
Competitive intelligence
What competitors actually claimed and tested for clearance.
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5
Submission posture memo
Recommended predicate, alternates, and posture rationale.
Frequently Asked Questions
De Novo vs. 510(k)?
Depends on novelty. We surface both pathways with realistic cost / timeline.
What if no clean predicate exists?
De Novo becomes likely. We map the path.
Can this feed our 510(k) writing directly?
Yes, the comparison work transfers to the submission.
How current is the data?
FDA databases are public; we use the most recent quarterly dataset.
Pick the predicate that earns you clearance.
Send us your device intended use. We will return predicate analysis within four weeks.
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